Boston Globe article which demonstrates to me that the biggest mistake in the whole brouhaha about thrombosis rates with cypher. Most of the damage will be to JNJ sales and I find it encouraging that this hospital still reports running out of stents at the beginning of each week. The scare may just help relieve shortages and I suspect the number of people who refuse cyphers in the next year as the result of this scare to be pretty small.
Olseth did indicate SRDX was in quite a turmoil on Wednesday. I did not appreciate that as much then as I do now. A pretty big deal for our financial well being as SRDX stockholders even if it will have an almost imperceptible effect on JNJ. Rather a poorly executed job by someone at the FDA and I suspect the error was not intentional. SRDX is just not big enough to be on anyone's hit list and JNJ will not be much affected, IMO.
Stent advisory sparks patient fears
Hospitals report flood of inquiries
By Benjamin Gedan, Globe Correspondent, 11/1/2003
Patients who have recently undergone surgery to unclog their arteries were "freaked out" yesterday by news this week that a life-saving device might not be so good after all.
Cardiologists in the region said they have been flooded with phone calls since the US Food and Drug Administration issued an advisory Wednesday, linking at least 60 deaths to a medicated tube, or stent, that props open clogged arteries and helps keep them from reclogging.
At Cape Cod Hospital, where 500 people have received the devices, 40 patients called to ask about the FDA advisory.
"They're greatly concerned," said Dr. Richard Zelman, the lead interventional cardiologist. "There are people walking around thinking they have a permanent time bomb inside them that can't be removed."
Zelman and other cardiologists were far less concerned than their patients, and said they would continue using the drug-coated Cypher stents, manufactured by Johnson & Johnson.
At Brigham and Women's Hospital, 50 stent recipients asked about the advisory, and the seven patients who received implants on Thursday required lengthy reassurances.
"We were able to convince all the patients to get the Cypher stent," said Dr. Jeffrey J. Popma, the hospital's director of interventional cardiology. "But it was after extensive discussion."
Doctors like the medicated stents because they have performed as promised, reducing the rate at which arteries reclog to under 10 percent; regular stents reclog about 30 percent of the time. Unfortunately, the medicated stent does nothing to prevent blood clots, known as thromboses. Both clots and reclogging, called restenosis, can be fatal.
The FDA issued its advisory because it wants to be sure the 200,000 Cypher stents installed since the device was approved in April aren't causing more clots than bare metal stents. Further research should be available in January.
The Cypher stent is used in 60 percent of stent procedures in the United States, and company officials said they have shipped 450,000 stents worldwide.
Demand for the tiny mesh cylinders has been so high that patients have delayed live-saving surgery to receive the $3,195 device, living with clogged arteries and inhibited blood flow, for weeks. In Boston, where doctors say a medically savvy population demands the newest technologies, many patients with lower risk chose to delay surgery, waiting up to three months for a Cypher.
Dr. Kenneth Rosenfield, director of cardiac and vascular invasive services at Massachusetts General Hospital, said over half the hospital's 2,500 annual angioplasties, a procedure that cleans out clogged arteries, now use Cypher stents. "We were running out of stents at the beginning of every week," he said.
An internal review at Beth Israel Deaconess Medical Center found no elevated risk of blood clots from the Cypher, said Dr. Joseph Carrozza, the hospital's chief of interventional cardiology.
But Carrozza said his patients "freaked out" after the FDA advisory, with more than 25 calling over the last two days. "We had a couple of patients say they wanted the stent taken out. The phones were ringing off the hook."
Carrozza said he still recommends the device, adding that thrombosis could occur from doctor error or a patient's failure to take anticlotting medication.
The Miami-based Cordis Corp., the Johnson & Johnson subsidiary that manufactures Cyphers, said the rate of reported problems with thrombosis was similar to that of bare metal stents, which have been used since 1994, and result in blood clots in less than 1 percent of patients.
Martin E. Schildhouse, a company spokesman, said FDA data was comparable to findings in clinical studies that led to government approval. The rate of blood clots is similar in Europe, where the Cypher has been used since April 2002, he said.
"We have no concern over the safety of our product," he said.
Tom Gross, director of the division of post-market surveillance for medical devices at the FDA, said the agency would not know the true risk of thrombosis until January, when Cordis plans to announce results from a 2,000-patient study.
Shamci Ghaffari, 54, received the Cypher in April 2002, after scar tissue reclogged her arteries following seven angioplasties. "I was living with fear all the time," she said.
For months, she said, she suffered chronic chest pain that left her awake at night worrying about a heart attack. She praised the Cypher yesterday, saying she was not concerned by the FDA advisory.
"I am extremely fine, God bless," she said. "In my case, it's a very, very good thing."
Benjamin Gedan can be reached at gedan@globe.com.
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